510(k) · Cleared

Cleared

Symmetric Total Knee Aguments

K100370510(k) TraditionalCleared Mar 7, 2011388-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Signal Medical Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Mar 7, 2011 as substantially equivalent to K043440 (Smith & Nephew, Inc., 2005) and 4 other predicates after a 388-day review. Its family tree reaches back 5 generations to 1998.

Decided: Mar 7, 2011
Review: 388 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 6

Its longest line of descent runs back 5 generations to K982302 (1998). 19 ancestors in all, the oldest K915132 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
4 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
3 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
2 generations backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
1 generation backK072336 Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp · 2007
This deviceK100370 Symmetric Total Knee AgumentsSignal Medical Corp. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K982302	Implex Continuum Knee - Hedrocel Tibial Spacers	Implex Corp.	1998	—
−4	K024161	Nexgen Complete Knee Solution - Trabecular Metal Augments	Implex Corp.	2003	2
−3	K040487	Trabecular Metal Knee System Augments	Implex Corp.	2004	1
−2	K053340	Trabecular Metal Tibial and Femoral Cone Augments	Zimmer Trabecular	2006	—
−1	K072336	Regenerex Porous Titanium Sleeve Augments	Biomet Manufacturing Corp	2007	—
0 (this device)	K100370	Symmetric Total Knee Aguments	Signal Medical Corp.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1995	2	0
1996	2	0
2000	1	0
2003	2	0
2004	3	0
2005	2	0
2006	1	0

FIG. 1 — Lineage of K100370, 1998–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JWH device

#1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K080199	FDA’s K080199 is Symmetric Total Knee System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Signal Medical Corporation	2008	1
*	K043440	Smith & Nephew, Inc. Revision Knee System Summary page 1 …21 CFR 888.3560 4. Predicate Device: SymmetriCTM Total Knee System (KOSO 199), Revision Knee System (K043440), Regenerex Ultra Porous Construct - Titanium Knee Augments (K053505),…	Smith & Nephew, Inc.	2005	7
*	K053505	Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments Summary page 1 …Revision Knee System (K043440), Regenerex Ultra Porous Construct - Titanium Knee Augments (K053505), Regenerex Porous Titanium Sleeve Augments (K072336),…	Biomet Manufacturing, Inc.	2006	—
*	K072336	Regenerex Porous Titanium Sleeve Augments Summary page 1 …us Construct - Titanium Knee Augments (K053505), Regenerex Porous Titanium Sleeve Augments (K072336), Trabecular Metal Tibia] Cone Augments and Trabecular…	Biomet Manufacturing Corp	2007	—
*	K053340	Trabecular Metal Tibial and Femoral Cone Augments Summary page 1 …K072336), Trabecular Metal Tibia] Cone Augments and Trabecular Metal Femoral Cone Augments (K053340), Genesis 11 Total Knee System (K(953274) Similarit…	Zimmer Trabecular	2006	—
*	K953274	Genesis Porous Tibial Trays & Revision Knee System Summary page 1 …ments and Trabecular Metal Femoral Cone Augments (K053340), Genesis 11 Total Knee System (K(953274) Similarities to these components are based on design,…	Smith & Nephew Richards, Inc.	1996	—

Also cleared against K043440: 10 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
11 of the 19 ancestors have a recall of any class.
10 other devices also cite its predicate K043440.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	4	—

What is it indicated for?

The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications.

1. Osteoarthritis

2. Rheumatoid Arthritis

3. Traumatic Arthritis or correction of posttraumatic joint deformity

4. Where the use of a more conservative procedure has failed or is unacceptable.

All components are for cemented use.

Additional indications for use:

* Whenever a cone is used, a revision stem is to be used as well.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100370 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100370: Symmetric Total Knee Aguments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100370

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026